NHGRI invites applications for research developing
comparative approaches that can be used to understand genome structure and
function and the relationship between genomic features and phenotypes. This program
supports studies that enable the use of a diverse array of species to advance
our ability to understand basic biological processes related to human health
and disease, as well as studies that develop novel analytical tools and
resources for the comparative genomics research community.

It is critical that applicants follow the Research (R) Instructions
in the SF424
(R&R) Application Guide, except where instructed to do otherwise (in
this FOA or in a Notice from the NIH
Guide for Grants and Contracts). Conformance to all requirements (both
in the Application Guide and the FOA) is required and strictly enforced. Applicants
must read and follow all application instructions in the Application Guide as
well as any program-specific instructions noted in Section IV. When the program-specific
instructions deviate from those in the Application Guide, follow the program-specific
instructions. Applications that do not comply with these instructions may
be delayed or not accepted for review.

There are several options available to submit your application through Grants.gov to NIH and
Department of Health and Human Services partners. You must use one of these submission
options to access the application forms for this opportunity.

Use the NIH ASSIST system to prepare, submit and track your application online.

Comparative genomics is a powerful means for understanding
the relationships among genome sequence, structure, and function. Comparisons
among the genomes of different species have provided insights into the
plasticity of genomes, have contributed to our understanding of the
relationship between genomic structure and function, and have helped to
elucidate functional elements of the genome. Studies of chromosomal
organization and gene order have contributed to our understanding of gene
silencing and functional gene clustering, studies of highly conserved genomic
elements have led to the identification of regulatory regions and highlighted
functional constraints, and studies of genomic regions that have diverged
rapidly or maintained large amounts of variation provide insight into the
evolution and biology of specific traits.

Comparative
genome sequencing

Initially, comparative studies focused on individual genes
or loci to understand specific regions, genomic features, and traits. Advances
in genomic sequencing have enabled comparisons between whole genomes of species
with reference or lower-quality assemblies. Until recently, these studies
relied largely on whole-genome sequence data from a few species, primarily
those used as model organisms for biomedical research. Improved technology and
reduced costs now allow investigators to sequence multiple species chosen to
address specific comparative genomics questions. For example, comparisons among
multiple distantly-related species can shed light on the evolutionary origins
of proteins; comparisons among species within one phylum (e.g., vertebrates)
can reveal constrained gene regulatory regions; comparisons among still more
closely-related species can reveal rapidly changing genomic regions associated
with changes in morphology or other phenotypes. Comparisons of species at
different phylogenetic distances can reveal the genomic underpinnings of
convergent phenotypes (e.g., loss of limbs in snakes and whales; advent of
multicellularity in independent eukaryotic lineages). Comparative genomic
analysis can provide information about the genomic basis for evolutionary
novelties and elucidate the biology of genomes in addition to resolving species
relationships and informing conservation biology. For each of these, the possibility
of obtaining data from multiple species enabled the community to address new
questions through the development and application of new approaches and
analytic methods for comparative genomics.

Although recent advances in technology have enabled more
genomes to be sequenced, many of those studies have been motivated by questions
that are not primarily related to comparative genomics. For example, many
organisms have been sequenced because they are used in specific areas of
biomedical research or agriculture.

This funding opportunity focuses on the development of approaches
and methods that will increase capacity to use primary data from multiple
species to address specific biological questions or sets of related questions;
while primary data may be generated and used to answer specific biological
questions under this funding opportunity, these should be used as proof of
principle for generalizable strategies, methods, and resources that are more
widely applicable.

Moving
beyond comparative genome sequence

This FOAFOA is not limited to studies of genomic sequence
data. Comparisons between organisms at the level of gene regulation or genome
organization may also inform many of the general questions above. Therefore,
applications that propose to develop approaches that use transcriptomic,
epigenomic, gene regulatory network, or other sequence-based, genome-wide
functional data types will also be considered.

Research objectives:

Awards under this FOAFOA will support development of new comparative
genomics research approaches using genomic data types to understands biological
systems, networks, and pathways. High priority will be given to applications
that propose innovative and promising approaches to genome-wide and
multi-species comparisons at the DNA, RNA, regulatory element, pathway, or
similar genomic levels; that enable answering novel questions or that
significantly improve the state-of-the-art; that integrate genomics and other
data types across a diversity of species; that develop new computational
methods, tools, and algorithms for using comparative genomics approaches to
study biological processes; that fully leverage multiple data types and
functional information available from diverse species; or that provide
comprehensive comparative genomics resources and tools for the community.
Studies of a single species or a small number of species are not encouraged,
and will only be considered when the data would address a biologically
important gap in knowledge and if this data would, when compared with data from
other species, contribute to an understanding of unique genomic features,
organizations, or functional mechanisms. Since a major goal of this FOA is to
provide access to genomic resources by the research community, awardees will be
required to actively disseminate the data and resources supported under these
awards.

Specific areas of research interest:

NHGRI is interested in supporting development of comparative
genomics methods and resources with strong justification of biological
relevance, particularly relevance to human health and disease, that will enable
areas of research including, but not limited to:

Genome structure and organization across multiple species,
particularly in lineages with diverse or unusual genomic architectures

The relationship between genomic structure and function,
especially in non-coding regions of the genome

Evolutionary patterns and processes across multiple species
including but not limited to divergent and convergent patterns of gene
modification, gene regulation (including splicing), regulatory element
activity, and regulatory networks

Better understanding of the relationship between changes in DNA
sequence, transcriptomic and epigenomic signatures, and phenotype/fitness,
given that they do not always have simple correlations;

The genetic underpinnings and evolution of health-related
function in multiple species;

The comparative population genomics of highly variable regions in
multiple species;

Integration of the genomes from ancient DNA and extant species to
elucidate the genetic bases and evolutionary forces underlying speciation,
adaptation to diverse environments, and the connections among genes,
environments, and phenotypic form and function.

This FOA is NOT intended for methods or resources addressing:

Population studies of single species;

Data generation or annotation of reference genomes from single
species;

Analyses that focus solely on proteomics, metabolomics, or other
molecules beyond nucleic acids;

Development of new model organism systems (this is supported
through other mechanisms).

In general, NHGRI supports studies that provide
generalizable methods and knowledge. Applications for studies relevant only to
a particular disease or organ system should be directed to the appropriate
Institute or Center. Applicants are strongly encouraged to contact NHGRI
Scientific/Research staff early in the development of an application to discuss
the alignment of their proposed work with the goals of NHGRI.

Successful awardees will be expected to attend a yearly
grantee meeting designed to facilitate the sharing of approaches, progress and
findings in comparative genomics.

The number of awards is contingent upon NIH appropriations
and the submission of a sufficient number of meritorious applications.

Award Budget

Application budgets are not limited but need to reflect the
actual needs of the proposed project.

Award Project Period

The scope of the proposed
project should determine the project period. The maximum project period
is 4 years, but given how quickly the field is evolving, in order to ensure
that the research is addressing the most current issues, many projects that
are funded will be no more than 3 years in duration.

NIH grants policies as
described in the NIH
Grants Policy Statement will apply
to the applications submitted and awards made in response to this FOA.

Section III. Eligibility
Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

Public/State Controlled Institutions of Higher Education

Private Institutions of Higher Education

The following types of Higher Education Institutions
are always encouraged to apply for NIH support as Public or Private
Institutions of Higher Education:

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible
to apply.
Foreign components, as defined in
the NIH Grants Policy Statement, are allowed.

Required
Registrations

Applicant
Organizations

Applicant organizations must complete and maintain the
following registrations as described in the SF 424 (R&R) Application Guide
to be eligible to apply for or receive an award. All registrations must be
completed prior to the application being submitted. Registration can take 6
weeks or more, so applicants should begin the registration process as soon as
possible. The NIH
Policy on Late Submission of Grant Applications states that failure to
complete registrations in advance of a due date is not a valid reason for a
late submission.

Dun and Bradstreet
Universal Numbering System (DUNS) - All registrations require that
applicants be issued a DUNS number. After obtaining a DUNS number, applicants
can begin both SAM and eRA Commons registrations. The same DUNS number must be
used for all registrations, as well as on the grant application.

System for Award Management (SAM) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least
annually. The renewal process may require as much time as the
initial registration. SAM registration includes the assignment of a Commercial
and Government Entity (CAGE) Code for domestic organizations which have not
already been assigned a CAGE Code.

eRA Commons - Applicants
must have an active DUNS number and SAM registration in order to complete the
eRA Commons registration. Organizations can register with the eRA Commons as
they are working through their SAM or Grants.gov registration. eRA Commons
requires organizations to identify at least one Signing Official (SO) and at
least one Program Director/Principal Investigator (PD/PI) account in order to
submit an application.

Grants.gov – Applicants
must have an active DUNS number and SAM registration in order to complete the
Grants.gov registration.

Program
Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.
PD(s)/PI(s) should work with their organizational officials to either
create a new account or to affiliate their existing account with the applicant
organization in eRA Commons. If the PD/PI is also the organizational Signing Official,
they must have two distinct eRA Commons accounts, one for each role. Obtaining
an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal
Investigator)

Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director(s)/Principal
Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH support.

Applicant organizations may submit more than one application,
provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping
applications under review at the same time. This means that the NIH will
not accept:

A new (A0) application that is submitted before issuance of the
summary statement from the review of an overlapping new (A0) or resubmission
(A1) application.

A resubmission (A1) application that is submitted before issuance
of the summary statement from the review of the previous new (A0) application.

An application that has substantial overlap with another application
pending appeal of initial peer review (see NOT-OD-11-101).

Section IV. Application and Submission Information

1. Requesting an
Application Package

Buttons to access the online ASSIST system or to download
application forms are available in Part
1 of this FOA. See your administrative office for instructions if you plan
to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the Research (R) Instructions
in the SF424
(R&R) Application Guide, including Supplemental
Grant Application Instructions except where instructed in this funding
opportunity announcement to do otherwise. Conformance to the requirements in
the Application Guide is required and strictly enforced. Applications that are
out of compliance with these instructions may be delayed or not accepted for
review.

Although a letter of intent is not required, is not binding,
and does not enter into the review of a subsequent application, the information
that it contains allows IC staff to estimate the potential review workload and
plan the review.

By the date listed in Part 1. Overview
Information, prospective applicants are asked to submit a letter of intent
that includes the following information:

All page limitations described in the SF424 Application
Guide and the Table of
Page Limits must be followed.

Instructions for Application Submission

The following section supplements the instructions found in
the SF424 (R&R) Application Guide and should be used for preparing an
application to this FOA.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide
must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide
must be followed.

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide
must be followed.

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide
must be followed.

R&R or Modular Budget

All instructions in the SF424 (R&R) Application Guide
must be followed. Applicants should budget for the PD/PI and up to two other
personnel to attend a yearly grantee meeting in the Bethesda area. This is in
addition to any budgeted travel to present findings at scientific meetings

R&R Subaward Budget

All instructions in the SF424 (R&R) Application Guide
must be followed.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide
must be followed.

PHS 398 Research Plan

All instructions in the SF424 (R&R) Application Guide
must be followed, with the following additional instructions:

Research
Strategy: As part of the significance section, applicants
should describe the generalizability and broader relevance of the proposed
research beyond the specific species targeted in the study. Applicants should clarify
the potential for the proposed work to contribute to our understanding of
biological processes and improve our understanding of the relationship of
genome function and human health. As part of the innovation section,
applicants should describe the novelty of their research, and detail how it is
distinct from existing research efforts in this area.

All applicants should include a strong rationale for species
selection. As much as possible, applicants are encouraged to use existing data
and should provide a strong rationale for new data generation.

Applicants proposing generation of new data should include
relevant information on sample collection and data generation methods;
applicants proposing use of existing data should provide details on the source
of the data, including quality control metrics and as much information as
possible about sample collection including the location and condition of the
source animals.

Resource
Sharing Plan: Individuals are required to comply with the
instructions for the Resource Sharing Plans as provided in the SF424 (R&R)
Application Guide

All applications, regardless of the amount of direct costs
requested for any one year, should address a Data Sharing Plan.

Resource sharing plans should specify plans for sharing of both
genomic and non-genomic (environmental, health, geographic, etc.) data,
including all metadata and descriptive information needed to support future use
of the data.

If the proposed work includes use of existing data, plans or
constraints for sharing such data should also be described. As part of this
plan, all final datasets, not just those generated to support a publication
should be submitted to appropriate data repositories, or made available through
NHGRI-approved alternative data sharing plans.

Resource sharing plans should include plans for open sharing of
software tools. Software is expected to be well-documented and made
available on version-controlled public repositories.

Resource sharing plans should include clear milestones and
timelines for data deposition and software release. Milestones should
adhere to standard data release timelines as outlined in the NIH Genomic Data Sharing Policy, and
NHGRI expectations for implementation
of this policy.

Appendix:

Limited items are allowed in the Appendix. Follow all
instructions for the Appendix as described in the SF424 (R&R) Application
Guide.

PHS Human Subjects and Clinical Trials Information

Use only for applications with due dates on or after January
25, 2018. When involving NIH-defined human subjects research, clinical
research, and/or clinical trials (and when applicable, clinical trials research
experience) follow all instructions for the PHS Human Subjects and Clinical
Trials Information form in the SF424 (R&R) Application Guide, with the
following additional instructions:

If you answered "Yes" to the question "Are Human Subjects
Involved?" on the R&R Other Project Information form, you must include at
least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials
Information form or a Delayed
Onset Study record.

Study
Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide
must be followed

Delayed
Onset Study

All instructions in the SF424 (R&R) Application Guide
must be followed.

PHS Assignment Request Form

All instructions in the SF424 (R&R) Application Guide
must be followed.

Foreign Institutions

Foreign (non-U.S.) institutions must follow policies
described in the NIH
Grants Policy Statement, and procedures for foreign institutions described
throughout the SF424 (R&R) Application Guide.

3. Unique Entity Identifier
and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the
requirement for obtaining a unique entity identifier and for completing and
maintaining active registrations in System for Award Management (SAM), NATO
Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and
Grants.gov

4. Submission Dates and
Times

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to
submit applications before the due date to ensure they have time to make any
application corrections that might be necessary for successful submission. When
a submission date falls on a weekend or Federal
holiday, the application deadline is automatically extended to the next
business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants
across all Federal agencies). Applicants must then complete the submission process
by tracking the status of the application in the eRA Commons, NIH's electronic system for grants
administration. NIH and Grants.gov systems check the application against many
of the application instructions upon submission. Errors must be corrected and a
changed/corrected application must be submitted to Grants.gov on or before the application
due date and time. If a Changed/Corrected application is submitted after the
deadline, the application will be considered late. Applications that miss the
due date and time are subjected to the NIH Policy on Late Application
Submission.

Applicants
are responsible for viewing their application before the due date in the eRA
Commons to ensure accurate and successful submission.

Information on the submission process and a definition of
on-time submission are provided in the SF424 (R&R) Application Guide.

For assistance with your electronic application or for more information on the electronic submission
process, visit Applying
Electronically. If you encounter a system issue beyond your control that
threatens your ability to complete the submission process on-time, you must
follow the Guidelines
for Applicants Experiencing System Issues. For assistance with application
submission, contact the Application Submission Contacts in Section VII.

Important
reminders:

All PD(s)/PI(s) must include their eRA Commons ID in
the Credential fieldof the Senior/Key Person Profile Component of the
SF424(R&R) Application Package. Failure to register in the Commons
and to include a valid PD/PI Commons ID in the credential field will prevent
the successful submission of an electronic application to NIH. See Section III of this FOA for information on
registration requirements.

The applicant organization must ensure that the DUNS
number it provides on the application is the same number used in the
organization's profile in the eRA Commons and for the System for Award Management.
Additional information may be found in the SF424 (R&R) Application Guide.

Upon receipt, applications will be evaluated for
completeness and compliance with application instructions by the Center for
Scientific Review, NIH. Applications that are incomplete or non-compliant will
not be reviewed.

Requests of $500,000 or more for direct costs in any year

Applicants requesting $500,000 or more in direct costs in
any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 6 weeks before submitting the application
and follow the Policy on the Acceptance for Review of Unsolicited Applications
that Request $500,000 or More in Direct Costs as described in the SF424
(R&R) Application Guide.

Post Submission Materials

Applicants are required to follow the instructions for
post-submission materials, as described in the policy.

Section V. Application Review Information

1.
Criteria

Only the review criteria described below will be considered
in the review process. As part of the NIH mission,
all applications submitted to the NIH in support of biomedical and behavioral
research are evaluated for scientific and technical merit through the NIH peer
review system.

Overall Impact

Reviewers will provide an overall impact score to reflect
their assessment of the likelihood for the project to exert a sustained,
powerful influence on the research field(s) involved, in consideration of the
following review criteria and additional review criteria (as applicable for the
project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in
the determination of scientific merit, and give a separate score for each. An
application does not need to be strong in all categories to be judged likely to
have major scientific impact. For example, a project that by its nature is not
innovative may be essential to advance a field.

Significance

Does the project address an
important problem or a critical barrier to progress in the field? Is there a
strong scientific premise for the project? If the aims of the project are
achieved, how will scientific knowledge, technical capability, and/or clinical
practice be improved? How will successful completion of the aims change the
concepts, methods, technologies, treatments, services, or preventative
interventions that drive this field?

Investigator(s)

Are the PD(s)/PI(s), collaborators,
and other researchers well suited to the project? If Early Stage Investigators
or
those in the early stages
of independent careers, do they
have appropriate experience and training? If established, have they
demonstrated an ongoing record of accomplishments that have advanced their
field(s)? If the project is collaborative or multi-PD/PI, do the investigators
have complementary and integrated expertise; are their leadership approach,
governance and organizational structure appropriate for the project?

Innovation

Does the application challenge and
seek to shift current research or clinical practice paradigms by utilizing
novel theoretical concepts, approaches or methodologies, instrumentation, or
interventions? Are the concepts, approaches or methodologies, instrumentation,
or interventions novel to one field of research or novel in a broad sense? Is a
refinement, improvement, or new application of theoretical concepts, approaches
or methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy,
methodology, and analyses well-reasoned and appropriate to accomplish the
specific aims of the project? Have the investigators presented strategies to
ensure a robust and unbiased approach, as appropriate for the work proposed? Are
potential problems, alternative strategies, and benchmarks for success
presented? If the project is in the early stages of development, will the
strategy establish feasibility and will particularly risky aspects be managed? Have
the investigators presented adequate plans to address relevant biological
variables, such as sex, for studies in vertebrate animals or human subjects?

If the project involves human
subjects and/or NIH-defined clinical research, are the plans to address 1) the
protection of human subjects from research risks, and 2) inclusion (or
exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as
well as the inclusion or exclusion of children, justified in terms of the
scientific goals and research strategy proposed?

Environment

Will the scientific environment in
which the work will be done contribute to the probability of success? Are the
institutional support, equipment and other physical resources available to the
investigators adequate for the project proposed? Will the project benefit from
unique features of the scientific environment, subject populations, or collaborative
arrangements?

Additional Review Criteria

As applicable for the project proposed, reviewers will
evaluate the following additional items while determining scientific and
technical merit, and in providing an overall impact score, but will not give
separate scores for these items.

Protections for Human Subjects

For research that involves human
subjects but does not involve one of the six categories of research that are
exempt under 45 CFR Part 46, the committee will evaluate the justification for
involvement of human subjects and the proposed protections from research risk
relating to their participation according to the following five review
criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3)
potential benefits to the subjects and others, 4) importance of the knowledge
to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human
subjects and meets the criteria for one or more of the six categories of
research that are exempt under 45 CFR Part 46, the committee will evaluate: 1)
the justification for the exemption, 2) human subjects involvement and
characteristics, and 3) sources of materials. For additional information on
review of the Human Subjects section, please refer to the Guidelines for the Review of Human
Subjects.

Inclusion of Women, Minorities,
and Children

When the proposed project involves
human subjects and/or NIH-defined clinical research, the committee will
evaluate the proposed plans for the inclusion (or exclusion) of individuals on
the basis of sex/gender, race, and ethnicity, as well as the inclusion (or
exclusion) of children to determine if it is justified in terms of the
scientific goals and research strategy proposed. For additional information on
review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion
in Clinical Research.

Vertebrate Animals

The committee will evaluate the
involvement of live vertebrate animals as part of the scientific assessment
according to the following criteria: (1) description of proposed procedures
involving animals, including species, strains, ages, sex, and total number to
be used; (2) justifications for the use of animals versus alternative models
and for the appropriateness of the species proposed; (3) interventions to
minimize discomfort, distress, pain and injury; and (4) justification for euthanasia
method if NOT consistent with the AVMA Guidelines for the Euthanasia of
Animals. Reviewers will assess the use of chimpanzees as they would any other
application proposing the use of vertebrate animals. For additional information
on review of the Vertebrate Animals section, please refer to the Worksheet
for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether
materials or procedures proposed are potentially hazardous to research
personnel and/or the environment, and if needed, determine whether adequate
protection is proposed.

Resubmissions

For Resubmissions, the committee
will evaluate the application as now presented, taking into consideration the
responses to comments from the previous scientific review group and changes
made to the project.

Renewals

For Renewals, the committee will
consider the progress made in the last funding period.

Revisions

For Revisions, the committee will
consider the appropriateness of the proposed expansion of the scope of the
project. If the Revision application relates to a specific line of
investigation presented in the original application that was not recommended
for approval by the committee, then the committee will consider whether the
responses to comments from the previous scientific review group are adequate
and whether substantial changes are clearly evident.

Additional Review Considerations

As applicable for the project proposed, reviewers will
consider each of the following items, but will not give scores for these items,
and should not consider them in providing an overall impact score.

Applications from Foreign
Organizations

Reviewers will assess whether the
project presents special opportunities for furthering research programs through
the use of unusual talent, resources, populations, or environmental conditions
that exist in other countries and either are not readily available in the
United States or augment existing U.S. resources.

Select Agent Research

Reviewers will assess the
information provided in this section of the application, including 1) the
Select Agent(s) to be used in the proposed research, 2) the registration status
of all entities where Select Agent(s) will be used, 3) the procedures that will
be used to monitor possession use and transfer of Select Agent(s), and 4) plans
for appropriate biosafety, biocontainment, and security of the Select Agent(s).

For projects involving key biological and/or chemical resources,
reviewers will comment on the brief plans proposed for identifying and ensuring
the validity of those resources.

Budget and Period of Support

Reviewers will consider whether the
budget and the requested period of support are fully justified and reasonable
in relation to the proposed research.

2. Review and Selection
Process

Applications will be evaluated for scientific and technical
merit by (an) appropriate Scientific Review Group(s), in accordance with NIH peer
review policy and procedures, using the stated review
criteria. Assignment to a Scientific Review Group will be shown in the eRA
Commons.

As part of the scientific peer review, all applications:

May undergo a selection process in which only those applications
deemed to have the highest scientific and technical merit (generally the top
half of applications under review) will be discussed and assigned an overall impact
score.

Will receive a written critique.

Applications will be assigned on the basis of established
PHS referral guidelines to the appropriate NIH Institute or Center. Applications
will compete for available funds with all other recommended applications. Following
initial peer review, recommended applications will receive a second level of
review by the appropriate national Advisory Council or Board. The following
will be considered in making funding decisions:

Scientific and technical merit of the proposed project as
determined by scientific peer review.

Availability of funds.

Relevance of the proposed project to program priorities.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI
will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer
to Part 1 for dates for peer review, advisory council review, and earliest start
date.

If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH
Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA)
will be provided to the applicant organization for successful applications. The
NoA signed by the grants management officer is the authorizing document and
will be sent via email to the grantee's business official.

Awardees must comply with any funding restrictions described
in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be
subject to terms and conditions found on the Award
Conditions and Information for NIH Grants website. This includes any
recent legislation and policy applicable to awards that is highlighted on this
website.

Recipients of federal financial
assistance (FFA) from HHS must administer their programs in compliance with
federal civil rights law. This means that recipients of HHS funds must ensure
equal access to their programs without regard to a person's race, color,
national origin, disability, age and, in some circumstances, sex and religion.
This includes ensuring your programs are accessible to persons with limited
English proficiency. HHS recognizes that research projects are often limited
in scope for many reasons that are nondiscriminatory, such as the principal
investigator's scientific interest, funding limitations, recruitment
requirements, and other considerations. Thus, criteria in research protocols
that target or exclude certain populations are warranted where
nondiscriminatory justifications establish that such criteria are appropriate
with respect to the health or safety of the subjects, the scientific study
design, or the purpose of the research.

In accordance with the statutory provisions contained in
Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal
Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal
Awardee Performance and Integrity Information System (FAPIIS) requirements.
FAPIIS requires Federal award making officials to review and consider
information about an applicant in the designated integrity and performance
system (currently FAPIIS) prior to making an award. An applicant, at its
option, may review information in the designated integrity and performance
systems accessible through FAPIIS and comment on any information about itself
that a Federal agency previously entered and is currently in FAPIIS. The
Federal awarding agency will consider any comments by the applicant, in addition
to other information in FAPIIS, in making a judgement about the applicant's
integrity, business ethics, and record of performance under Federal awards when
completing the review of risk posed by applicants as described in 45 CFR Part
75.205 "Federal awarding agency review of risk posed by applicants." This
provision will apply to all NIH grants and cooperative agreements except
fellowships.

A final RPPR, invention statement,
and the expenditure data portion of the Federal Financial Report are required for
closeout of an award, as described in the NIH
Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of
2006 (Transparency Act), includes a requirement for awardees of Federal grants
to report information about first-tier subawards and executive compensation
under Federal assistance awards issued in FY2011 or later. All awardees of
applicable NIH grants and cooperative agreements are required to report to
the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH
Grants Policy Statement for additional information on this reporting
requirement.

In accordance with the regulatory requirements provided at
45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have
currently active Federal grants, cooperative agreements, and procurement
contracts from all Federal awarding agencies with a cumulative total value
greater than $10,000,000 for any period of time during the period of
performance of a Federal award, must report and maintain the currency of
information reported in the System for Award Management (SAM) about civil,
criminal, and administrative proceedings in connection with the award or
performance of a Federal award that reached final disposition within the most
recent five-year period. The recipient must also make semiannual
disclosures regarding such proceedings. Proceedings information will be
made publicly available in the designated integrity and performance system
(currently FAPIIS). This is a statutory requirement under section 872 of
Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010
of Public Law 111-212, all information posted in the designated integrity and
performance system on or after April 15, 2011, except past performance reviews
required for Federal procurement contracts, will be publicly available. Full
reporting requirements and procedures are found in Appendix XII to 45 CFR Part
75 – Award Term and Conditions for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.